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Effects of Personalized Insoles on Pain Relief

Effects of Personalized Insoles on Pain Relief and Quality of Life in Middle-Aged and Elderly Adults: A Prospective Cohort Study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1040250097
Enrollment
15
Registered
2025-09-12
Start date
2025-09-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic anlke, knee and Back pain

Interventions

wearing a Personal insole

Sponsors

Takegami Yasuhiko
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Aged 60 years or older (male or female). Presence of chronic ankle, knee, or low back pain for at least 6 months, with a Visual Analogue Scale (VAS) score of 40 mm or higher. Independent in Activities of Daily Living (ADL), though the use of a cane is permitted. Foot structure suitable for wearing insoles (i.e., no severe deformities). Capable of providing written informed consent.

Exclusion criteria

Exclusion criteria: Participants who meet any of the following criteria will be excluded: Diagnosis of dementia, a severe psychiatric disorder, or a neurological condition that impairs communication. Presence of severe osteoarthritis, trauma, or post-operative conditions in the lower limbs that significantly restrict walking. Significant abnormalities in foot sensation or circulation, such as diabetic neuropathy or peripheral vascular disease. A history of strong discomfort or allergic reaction to insoles. Any individual deemed unsuitable for participation by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale (VAS) Assessment Sites: Ankle, knee, and low back

Secondary

MeasureTime frame
Secondary Outcomes Change in disease-specific index for low back pain: Measured by the Bath Ankylosing Spondylitis Disease Activity Index (BSDAI). Change in Quality of Life (QOL): Measured by the SF-36 Questionnaire. Change in joint function: Measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Change in physical activity: Measured by average daily step count. Adherence to insole use: Measured by continuation rate and daily wearing time.

Contacts

Public ContactYasuhiko Takegami

Nagoya university Hospital

takegami.yasuhiko.k3@f.mail.nagoya-u.ac.jp+81-52-744-21111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026